Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
133
Countries
2
Sites
4
Part C: advanced or unresectable STs (Spain only)
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Jul 2017 → 7 Sep 2024
- Decision date (initial)
- 2024-02-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509969-20-00
- EudraCT number
- 2015-004371-79
- WHO UTN
- U1111-1194-8570
- ClinicalTrials.gov
- NCT03220347
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Part C: advanced or unresectable STs (Spain only)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 23.0 | PT | 10029600 | Non-Hodgkin's lymphoma recurrent | 100000004864 |
| 23.0 | PT | 10029601 | Non-Hodgkin's lymphoma refractory | 100000004864 |
| 21.0 | PT | 10012822 | Diffuse large B-cell lymphoma refractory | 100000004864 |
| 21.0 | PT | 10012821 | Diffuse large B-cell lymphoma recurrent | 100000004864 |
| 20.0 | PT | 10004146 | Basal cell carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 15 | 1 |
| Spain | Ended | 112 | 3 |
| Rest of world
Japan
|
— | 6 | — |
Investigational sites
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Ematologia Oncologica, Via Mariano Semmola 52, 80131, Naples
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2019-05-24 | 2019-07-19 | 2020-10-16 | ||
| Spain | 2017-07-24 | 2017-07-24 | 2020-12-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-30 | Spain | Acceptable 2024-02-21
|
2024-02-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-15 | Spain | Acceptable 2024-02-21
|
2024-03-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-02 | Spain | Acceptable 2024-02-21
|
2024-07-02 |